Translation of "study phase" to Slovene language:
Examples (External sources, not reviewed)
| Phase III study in | Študija III. faze za cervikalno distonijo |
| Phase III study in | Študija III. faze za blefarospazem (MRZ |
| 2007 (2009) Project is still in study phase | 2007 (2009) Projekt je še vedno v fazi preučitve |
| 2010 (2012) Project is still in study phase | 2010 (2012) Projekt je še vedno v fazi preučitve |
| The MAH focused the discussion on the pivotal randomized Phase 3 Study JHQJ, and the main supportive single arm Phase 2 Study JHRW. | Imetnik dovoljenja za promet z zdravilom je razpravo osredotočil na osrednjo radomizirano študijo 3. faze JHQJ in glavno podporno študijo 2. faze JHRW z enim krakom. |
| 8.2 in the cervical dystonia Phase III study, respectively). | Najpogostejši, vsaj morebiti z zdravljenjem povezani neželeni dogodek je bila disfagija (5, 2 za zdravilo Xeomin v primerjavi s 3, 4 za zdravilo Botox v združenem vzorcu ter 10 za zdravilo Xeomin v primerjavi z 8, 2 za zdravilo Botox v študiji III. faze za cervikalno distonijo). |
| 6 Safety data The numbers of adverse events in Phase II study and in Phase III dystonia Study are submitted in the following Table | 7 Podatki o varnosti Števila neželenih dogodkov v študiji II. faze in študiji III. faze za distonijo so podana v naslednji tabeli |
| In addition, children have been treated in two phase I studies and one phase II study. | Poleg tega so zdravili otroke v dveh študijah prve faze in eni študiji druge faze. |
| Study 2 was a Phase II, discontinuation study in patients with metastatic malignancies, including RCC. | Študija 2 je bila izključitvena študija II. faze, v katero so bili vključeni bolniki z različnimi vrstami metastatskega raka, tudi s KLC. |
| Study 1 (study 11213) was a Phase III, multi centre, randomised, double blind, placebo controlled study in 903 patients. | Študija 1 (študija 11213) je bila multicentrična, randomizirana, dvojno slepa, s placebom kontrolirana študija III. faze, v katero so bili vključeni 903 bolniki. |
| This study consisted of two phases, a placebo controlled phase followed by a pre planned follow up phase. | Preskušanje je imelo dve obdobji, s placebom kontroliranemu obdobju je sledilo vnaprej načrtovano obdobje spremljanja. |
| This study consisted of two phases, a placebo controlled phase followed by a pre planned follow up phase. | Ta študija je imela dva dela s placebom kontroliranemu prvemu delu je sledil vnaprej načrtovan kontrolni del študije. |
| The phase II trial (study 001 007) enrolled only women who | V preskušanje II. faze (študija 001 007) so bile vključene le ženske, ki |
| Selected Adverse Drug Reactions Reported in Phase III Dose Optimisation Study | Nekateri neželeni učinki zdravila, o katerih so poročali v študiji III. faze za optimalnega odmerka |
| Selected Adverse Drug Reactions Reported in Phase III Dose Optimisation Study | Nekateri neželeni učinki zdravila, o katerih so poročali v študiji III. faze za določitev optimalnega odmerka |
| One Phase 2 study (Study 065) and one Phase 3 study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed 90 days after completion of one prior regimen of chemotherapy. (see Table 1). | 8 Za oceno učinkovitosti peroralnega topotekana v primerjavi z intravenskim topotekanom pri bolnikih, ki se jim je pojavil relaps 90 dni po koncu ene predhodne sheme kemoterapije, sta bili narejeni ena študija 2. faze (študija 065) in ena študija 3. faze (študija 396) (glejte tabelo 1). |
| One Phase 2 study (Study 065) and one Phase 3 study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed 90 days after completion of one prior regimen of chemotherapy. (see Table 1). | 20 študija 2. faze (študija 065) in ena študija 3. faze (študija 396) (glejte tabelo 1). |
| In a phase I dose escalation study in NSCLC patients who were | Temu učinku se je pridružilo tudi zmanjšanje navideznega plazemskega očistka erlotiniba za 24 . |
| The applicant presented efficacy data of Phase III study in spasmodic torticollis. | Vlagatelj je predložil podatke o učinkovitosti iz študije III. faze za spastični tortikolis. |
| Frequency of adverse drug reactions reported in confirmatory phase III study (N 409). | Pogostnost neželenih reakcij na zdravilo, o katerih so poročali v potrditveni študiji faze III (N 409). |
| In clinical trials, luteal phase support was given according to study centres practice. | V kliničnih preskušanjih so dajali podporo lutealne faze glede na prakso raziskovalnega centra. |
| Phase I Study of TRISENOX (arsenic trioxide) injection in Patients with Hepatocellular Carcinoma | Študija prve faze injiciranja zdravila TRISENOX (arzenovega trioksida) bolnikom s hepatocelularnim karcinomom. |
| At 28 days, the mortality rate in the Phase 3b study was 25.3 . | Po 28 dnevih je bila stopnja umrljivosti v študiji faze 3b 25, 3 . |
| A second phase of the TEEB study will provide policy conclusions in 2009. | Druga stopnja študije TEEB bo leta 2009 postala osnova za sklepe o politiki. |
| A study shall have one phase and be concluded by the final report. | Študija ima eno fazo in bo končana s končnim poročilom. |
| One death (colon carcinoma), assessed as unrelated to study treatment (Botox), was reported during the Phase II cervical dystonia study. | Med študijo II. faze za cervikalno distonijo so poročali o enem smrtnem primeru (karcinom kolona), ki je bil ocenjen kot nepovezan z obravnavanim zdravljenem (Botox). |
| Hepatocellular carcinoma Study 3 (study 100554) was a Phase III, international, multi centre, randomised, double blind, placebo controlled study in 602 patients with hepatocellular carcinoma. | 10 Karcinom jetrnih celic Študija 3 (študija 100554) je bila mednarodna, multicentrična, randomizirana, dvojno slepa, s placebom kontrolirana študija III. faze pri 602 bolnikih s karcinomom jetrnih celic. |
| A further exploratory analysis of duration of effect employed data from a Phase II study in addition to the Phase III data described. | 6 V nadaljnjih raziskovalnih analizah trajanja učinka so poleg podatkov iz raziskave III faze uporabili tudi podatke iz raziskave II faze. |
| The Allopurinol and Placebo Controlled Efficacy Study of Febuxostat (APEX) was a Phase 3, randomized, double blind, multicenter, 28 week study. | Z alopurinolom in s placebom kontrolirana študija učinkovitosti febuksostata (Allopurinol and Placebo Controlled Efficacy Study of Febuxostat APEX) je bila randomizirana, dvojno slepa, multicentrična, 28 tedenska študija 3. faze. |
| The indication in pancreatic cancer is based on data from the pivotal Phase 3 study JHAY and the supporting study JHAZ. | Indikacija rak trebušne slinavke temelji na podatkih iz ključne študije III. faze JHAY in podporne študije JHAZ. |
| Patients who identified an effective dose entered the double blind phase of the study. | Bolniki, pri katerih je bil učinkovit odmerek ugotovljen, so bili uvrščeni v dvojno slepo fazo študije. |
| Study 1 included an open label phase, in which patients themselves elected to enrol. | Študija 1 je zajemala odprto fazo, v kateri so se bolniki sami odločili za sodelovanje. |
| There was no evidence of cumulative thrombocytopenia, including in the Phase II extension study. | O kumulativni trombocitopeniji ni bilo podatkov, kar velja tudi za podaljšanje preskušanja II. faze. |
| Common adverse reactions ( 1 100, 1 10) in the phase III osteoporosis study BM16550 after one year of treatment and in the phase III anti fracture study MF 4411 (three year study), that were considered by the investigator to be possibly or probably related to study medicinal product. | Pogosti neželeni učinki ( 1 100, 1 10) v fazi III študije pri osteoporozi BM 16550 po enem letu zdravljenja in v fazi III študije, ki je proučevala učinkovitost proti zlomom MF 4411 (triletna študija), za katere je raziskovalec menil, da so možno ali verjetno povezani z zdravilom v preskušanju. |
| Common adverse reactions ( 1 100, 1 10) in the phase III osteoporosis study BM16550 after two years of treatment (cumulative data) and in the phase III anti fracture study MF 4411 (three year study), that were considered by the investigator to be possibly or probably related to study medicinal product. | Pogosti neželeni učinki ( 1 100, 1 10) v fazi III študije pri osteoporozi BM 16550 po dveh letih zdravljenja (kumulativni podatki) in v fazi III študije, ki je proučevala učinkovitost proti zlomom MF 4411 (triletna študija), za katere je raziskovalec menil, da so možno ali verjetno povezani z zdravilom v preskušanju. |
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